Methods and elements for identifying the appropriate patient populations who can safely use prescription chronic care drugs that are switched to an over-the-counter regulatory status

Abstract

A method of administering an over the counter drug for treatment of a chronic medical condition to a patient is provided wherein a drug label for over-the-counter treatment of a chronic medical condition is created which requires a new patient to take an initial point-of-service diagnostic test to determine whether the patient suffers from the condition treated by the drug and requires patients already receiving the drug on an over-the-counter basis to take one or more follow up point-of-service diagnostic tests to determine whether the patient is benefiting from the drug and are not experiencing undue side effects. Patients determined eligible to take the drug may then be provided with a random access code for use in association with a lockable, electromechanical cabinet by means of which the patient can receive an appropriate dose of the drug to treat the patient's chronic medical condition. In certain embodiments, a follow up point-of-service diagnostic test determines whether the patient is experiencing any undue side effects from the drug. In further embodiments, a national patient registry for containing the point of service diagnostic test results is created for access by appropriate health care professionals.

What is claimed is: 
     
         1 . A method of dispensing a medication over-the-counter to human patients in need thereof, comprising
 administering a diagnostic test to human patients at a retail point of sale location for drugs using a point-of-sale, CLIA-waived diagnostic machine in order to screen the patients and determine whether the patients have disease conditions or biomarkers which indicate the suitability of drug therapy for a particular disease, wherein the drug has a condition-of-use drug label approved by a regulatory authority which authorizes over-the-counter dispensing of the drugs upon a determination at the point of sale that the patients are in need of treatment with the drug based on the results of diagnostic test; and   offering to the patients a drug regimen comprising a plurality of unit doses of a suitable dosage of a drug for the treatment of a particular disease if the result of the diagnostic test indicates that the patients would benefit from treatment with the drug.   
     
     
         2 . The method of  claim 1 , further comprising utilizing a retail healthcare person to analyze the results of the diagnostic test. 
     
     
         3 . The method of  claim 1 , further comprising providing the patients who would benefit from treatment with the drug with a random access code, so that the patients having the random access code can enter the code into a lockable, over-the-counter dispensing cabinet which will then dispense said plurality of unit doses of said drug to the patients. 
     
     
         4 . The method of  claim 2 , further comprising having the retail healthcare person dispense the drugs. 
     
     
         5 . The method of  claim 1 , further comprising entering the results of the diagnostic tests of the human patients into a national patient registry so that the patients who would benefit from treatment with the drug can purchase the drug at a different retail point of sale location which has access to the national patient registry. 
     
     
         6 . The method of  claim 1 , further comprising advising the patient that they must be administered a follow-up test prior to receiving a refill of the drug regimen. 
     
     
         7 . The method of  claim 6 , further comprising
 administering to said patients who receive the drug regimen a second diagnostic test at a retail point of sale location for drugs using a point-of-sale, CLIA-waived diagnostic machine in order to determine whether the patients' condition is being adequately treated with the dosage regimen and/or whether the patients are experiencing any problematic side effects, and   dispensing a second drug regimen to the patients if the result of the diagnostic test indicates that the patients would continue to benefit from treatment with the drug.   
     
     
         8 . The method of  claim 7 , further comprising providing the patients who would continue to benefit from treatment with the drug with the ability to obtain long-term refills of the drug regimen at retail point of sale locations having access to the national patient registry. 
     
     
         9 . The method of  claim 1 , wherein drug regimen is suitable for treatment of a chronic condition in human patients which can be adequately treated on an over-the-counter basis under a condition-of-use drug label utilizing data obtained from the point-of-sale, CLIA-waived diagnostic machine and evaluated by a retail healthcare person. 
     
     
         10 . The method of  claim 8 , wherein the drug is chosen from the group consisting of a drug for cholesterol reduction, a drug for diabetes control, a drug for medical obesity, a drug for control of hypertension, and a drug for treating benign prostatic hyperplasia. 
     
     
         11 . The method of  claim 9 , wherein the drug is lovastatin, simvastatin, pravastatin, atorvastatin, metformin, pioglitazone, liraglutide, sitagliptin, saxagliptin, canagliflozin, chloropropamide, glimepiride, glyburide, tolazamide, tolbutamide, a combination of phentermine and topiramate, lorcaserin, valsartan, metoprolol, atenolol, propranolol, carvedilol, amlodipine, olmesartan meloxomil, losartan, irbesartan, a combination of amlodipine and benazepril, aliskiren, a combination of hdrochlorothiazide and losartan, ramipril,lotensin, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, trandolapril, candesartan, telmisartan, diltiazem, terazosin, prazosin, alfuzosin, finasteride, dutasteride, tamsulosin, and doxazosin. 
     
     
         12 . The method of  claim 9 , wherein the drug is in the form of an oral solid dosage form. 
     
     
         13 . The method of  claim 12 , wherein the CLIA-waived diagnostic machine comprises an analyzer, further comprising inserting into the analyzer a test panel or disc along with a fluid sample comprising a drop of blood or saliva from the patients, the diagnostic machine being capable of analyzing the fluid sample for a particular disease or condition. 
     
     
         14 . The method of  claim 1 , further comprising
 administering to said patients who receive the drug regimen a second diagnostic test at a retail point of sale location for drugs using the CLIA-waived diagnostic machine in order to determine whether the patients' condition is being adequately treated with the dosage regimen and/or whether the patients are experiencing any problematic side effects, wherein the test protocol is capable of analyzing a second fluid sample taken from the patients in order to determine the patients' response or lack thereof to the drug as well as other biomarkers to determine asymptomatic side effects, and   dispensing a second drug regimen to the patients if the result of the diagnostic test indicates that the patients would continue to benefit from treatment with the drug.   
     
     
         15 . A method of treating human patients on an over-the-counter basis with a drug typically dispensed to patients only with a prescription from a healthcare person, comprising
 obtaining a condition-of-use drug label which requires a point-of-sale, CLIA-waived diagnostic test for determining whether a human patient's condition is being adequately treated with the drug and/or whether the patients are experiencing any problematic side effects with said drug, wherein the condition-of-use drug label requires the administration of a diagnostic test at a retail point of sale location for drugs using a point-of-sale, CLIA-waived diagnostic machine in order to determine whether the patient would continue to benefit from treatment with the drug, which would allow patients who would continue to benefit from treatment with the drug the ability to obtain long-term refills of the drug on an OTC basis.   
     
     
         16 . The method of  claim 15 , administering to said patients who have received the drug a diagnostic test at a retail point of sale location for drugs using a point-of-sale, CLIA-waived diagnostic machine in order to determine whether the patient would continue to benefit from treatment with the drug. 
     
     
         17 . The method of  claim 15 , further comprising dispensing one or more refills of the drug to the patient if the result of the diagnostic test indicates that the patient would continue to benefit from treatment with the drug. 
     
     
         18 . The method of  claim 15 , further comprising entering the results of the diagnostic test of the human patient into a national patient registry so that the patient can purchase the drug at a different retail point of sale location which has access to the national patient registry, if the diagnostic test determines that the patient would benefit from continued treatment with the drug. 
     
     
         19 . The method of  claim 18 , further comprising providing the patients who would continue to benefit from treatment with the drug with the ability to obtain long-term refills of the drug regimen at retail point of sale locations having access to the national patient registry. 
     
     
         20 . The method of  claim 15 , wherein the CLIA-waived diagnostic machine comprises an analyzer, further comprising inserting into the analyzer a test protocol along with a fluid sample comprising a drop of blood or saliva from the patients, the test protocol being capable of analyzing the fluid sample for a particular disease or condition.